Food and Drug Administration (FDA)
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In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
If the panel votes in favor of the vaccine for children, it will move to the U.S. CDC. If both agencies support the data, children this age would be likely to receive their first shots in early November.
Initial results showed a strong neutralizing antibody response and favorable safety profile among the participants.
Xipere was approved for suprachoroidal use for the macular edema treatment. Macular edema is associated with uveitis, it is a form of eye inflammation.
Researchers found improvements in the study’s co-primary endpoints in patient-reported measures of esophageal inflammation and difficulty swallowing.
The U.S. FDA has a busy period at the end of October heading into the first week of November.
A growing number of studies show that though natural immunity can work, hybrid immunity through vaccination could be better. They urge faster vaccination drives.
Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
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